Diagnostic Instruments for Autism in Deaf Children Study (DIADS)
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|ClinicalTrials.gov Identifier: NCT01932515|
Recruitment Status : Unknown
Verified June 2014 by Leeds and York Partnership NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : August 30, 2013
Last Update Posted : June 26, 2014
The trial is in three stages and will translate and validate screening and assessment instruments for use with deaf children.
The first stage is modifying the screening and assessment instruments (ADI-R and ADOS-2) for use with deaf children. This will involve choosing the most promising screening instrument (SRS-2) based on the systematic review and the expertise of a review panel, which contains experts and public and patient involvement (PPI). This phase of the study seeks a wide range of user (parents/ carers and young people) views and experiences about the symptomatology and presentation of deaf children with autism, comparing this to hearing children with autism, and deaf children without autism.
The second stage is to ensure that the newly modified instruments are accessible to deaf children and deaf parents by making any necessary translations from English into British Sign Language. This involves a strict translation and back translation methodology with reiterations until successful translation is achieved.
For stage three in order to ensure that the new questionnaires are successfully identifying children and young people with Autism Spectrum Disorder, the modified instrument will be validated using a 'gold standard'. The current 'gold standard' for the mental health screening of Deaf children is a clinical interview administered by experienced senior multidisciplinary deaf child mental health clinicians.
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss ASD||Behavioral: A revised screening instrument for use in Deaf children||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||325 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Instruments for Autism in Deaf Children Study|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||April 2017|
|No Intervention: Screening||Behavioral: A revised screening instrument for use in Deaf children|
- A validated Autism Spectrum Disorder screening instrument to identify those in need of further assessment from deaf children suspected of ASD, with both English and BSL versions (for deaf parents). [ Time Frame: 42 months ]
- A modified version of the Autism Diagnostic Interview Revised (ADIR) validated for use in the assessment of deaf young people; accessible in English and BSL (for hearing and deaf parents to fully participate in assessment). [ Time Frame: 42 months ]
- A modified version of the Autism Diagnostic Observation Schedule (ADOS 2) validated for use with deaf young people in both BSL or English. [ Time Frame: 42 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932515
|Leeds and York Partnership NHS Foundation Trust|
|York, North Yorkshire, United Kingdom, YO30 5RE|
|Principal Investigator:||Barry Wright||Leeds and York Partnership NHS Foundation Trust|